By Nikolaj Skydsgaard and Jacob Gronholt-Pedersen
Copenhagen: Health authorities in Denmark, Norway and Iceland say they have temporarily suspended the use of AstraZeneca’s COVID-19 vaccine after reports of the formation of blood clots in some who have been vaccinated.
Austria earlier stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.
Norway said its decision to temporarily suspend use of the vaccine was “a cautionary decision”.
Still, the European medicine regulator EMA said the vaccine’s benefits outweighed its risks and could continue to be administered.
Europe is struggling to speed up a vaccine rollout after delivery delays from Pfizer and AstraZeneca, even as a spike in cases amid a more contagious virus variant has triggered fresh lockdowns in countries like Italy and France.
Danish authorities said they had responded “to reports of possible serious side effects, both from Denmark and other European countries”.
“It is currently not possible to conclude whether there is a link. We are acting early, it needs to be thoroughly investigated,” Health Minister Magnus Heunicke said on Twitter.
The vaccine rollout would be suspended for 14 days in Denmark.
“This is a cautionary decision,” Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health (FHI), told a news conference.
FHI did not say how long the suspension would last.
“We … await information to see if there is a link between the vaccination and this case with a blood clot,” Bukholm said.
On the same day Iceland suspended jabs with the vaccine as it awaited the results of an investigation by the EMA, and Italy also said it would suspend use of a batch different to the one used in Austria.
Some health experts said there was little evidence to suggest the AstraZeneca vaccine should not be administered, and that the cases of blood clots corresponded with the rate of such cases in the general population.
“This is a super-cautious approach based on some isolated reports in Europe,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.
“The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence,” he said, adding that the COVID-19 disease was very strongly associated with blood clotting.
AstraZeneca on Thursday said in a written statement that the safety of its vaccine had been extensively studied in human trials and peer-reviewed data had confirmed the vaccine was generally well tolerated.
The drugmaker said earlier this week its shots were subject to strict and rigorous quality controls and that there had been “no confirmed serious adverse events associated with the vaccine”. It said it was in contact with Austrian authorities and would fully support their investigation.
The European Union’s drug regulator, the European Medicines Agency (EMA), said on Wednesday there was no evidence so far linking AstraZeneca to the two cases in Austria.
It said the number of thromboembolic events – marked by the formation of blood clots – in people who have received the AstraZeneca vaccine is no higher than that seen in the general population, with 22 cases of such events being reported among the 3 million people who have received it as of March 9.
EMA was not immediately available for comment on Thursday.
Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have stopped inoculations from the batch while investigations continue, the EMA said.
The batch of 1 million doses went to 17 EU countries.
Swedish authorities said they did not find sufficient evidence to stop vaccination with AstraZeneca’s vaccine. Sweden has found two cases of “thromboembolic events” in connection with AstraZeneca’s vaccine and about ten for the Pfizer-BioNTech vaccine.
“We see no reason to revise our recommendation,” Veronica Arthurson, head of drug safety at the Swedish Medical Products Agency, told a news conference. “There is nothing to indicate that the vaccine causes this type of blood clots.”
French Health Minister Olivier Veran said on Thursday that French health authorities see no reason to suspend the use of AstraZeneca COVID-19 vaccinations.
“The benefits of the AstraZeneca vaccine are higher than the risks,” Veran said at the goverment’s weekly coronavirus briefing.